HEALTHCARE ENTERPRISE: Diatherix , Grimaud's Newest Venture, Markets First Clinical Swine Flu Test
The first clinically available test to determine whether a patient has the H1N1 virus, commonly known as the swine flu, was developed in less than a week and released on May 7 by Diatherix Laboratories, which has administrative offices in Brentwood and laboratories in Huntsville, Ala.
To Nashville's biomedical community, the name of Diatherix's chairman and chief operating officer is a familiar one: Dennis Grimaud. A founding member and former director of the Nashville Health Care Council and founding chairman and president of the Tennessee Biotechnology Association, Grimaud boasts a 30-year career in the healthcare industry and has been the driving force behind more than a few successful biotechnology startups and spinoffs.
Diatherix, in fact, is a spinoff from Genaco Biomedical Products, which was based in Huntsville with Grimaud at the helm from 2004 to 2006. Genaco was sold to a German firm, yet Grimaud requested to license the technology back as the foundation for Diatherix, which he launched in 2007. "You know that Nashville Health Care Council Family Tree? It's the same basic premise," he remarked. By August 2008, Diatherix had completed CLIA certification. The federal Clinical Laboratory Improvement Amendments are designed to ensure quality laboratory performance for human tests, but not for research. CLIA certification is required to receive Medicare or Medicaid payments.
Diatherix specializes in infectious disease diagnostics, and its patented technology, called Target Enriched Multiplex Polymerase Chain Reaction (Tem-PCR) allows scientists to test a sample for several possible pathogens at once. "Single patient, single sample, multiple results," Grimaud said. The technology was developed by Diatherix's laboratory director, Jian Han, MD, PhD, who earned a doctorate from the University of Alabama at Birmingham in molecular medical genetics in 1991. He was the founder of Genaco in 1996.
"His ability to be able to look at the sequence and to look at the actual mutations and then be able to develop the primers to identify these individual pathogens is just amazing. It really is," Grimaud said of Han. When news of the swine flu began to spread earlier this spring, Grimaud went to Han about developing an H1N1 diagnostic test. "Well, he had already starting working on it," Grimaud recalled.
Han developed the test once federal researchers with the Centers for Disease Control and Prevention released H1N1's genetic information. "Most of my work is actually done on computer, and 80 percent of the work was done by somebody else – they already collected patient samples, isolated the virus, sequenced the genetic information from this virus and put the information online," Han said. "Based on that genetic information, we were able to find the genes that are unique to only the swine flu, not regular other flu, not other pathogens, not human DNA. Then we designed our assay just targeting that portion of the DNA – or RNA in this case – that is swine-flu specific, and we can amplify it."
Diatherix's test is particularly valuable because of the Tem-PCR technology, which allows researchers to test a sample for four different swine flu-specific genes. That's important because of the swine flu's ability to mutate. "That gives us the security, the insurance. If a mutation knocks out two out of the four, we can still detect the virus," Han said. "This is critical, and it also makes our technology superior to other technology."
Within four days of the test's release, Diatherix had already tested more than 100 samples received from hospitals and physician offices. The laboratory receives samples via FedEx, which is set up for the shipping of infectious agents. Test results are released to the shipper in six hours or less. "Our capability is pretty significant, because of the nature of our technology," Grimaud said. "If we had an actual outbreak of a pandemic … and we had thousands of samples … then it might put a strain on us, but this one is rolling out very slowly."
While Han said it's certainly too late to isolate and contain H1N1, Diatherix's test will help prevent unnecessary cautions, such as closing a school, because fast results could rule out the pathogen. Because of the test's multiplex ability, it also may tell the physician what the pathogen is – influenza A, for example. "You are sick, that's obvious, but sick from what? If you run our test, you have a much higher chance of knowing exactly what you are sick from. Therefore there's no panic. You see, the panic is associated with the unknown," Han said. He was also responsible for developing the Tem-PCR avian flu test for the Asian strain of H5N1, as well as a respiratory infection differentiation test used during the SARS outbreak in China.
Diatherix's other testing products include:
- Staphylococcus differentiation panel aimed at hospital-acquired infections such as MRSA.
- Healthcare-associated infection panel, which includes the Staphylococcus panel, and is used primarily by wound clinics and other providers that treat severe wounds that may be co-infected.
- Viral respiratory panel and a respiratory infection panel with 27 pathogens, both viral and bacterial.
- Bacterial pneumonia panel, used primarily to ensure that at-risk patients transferring into a hospital, perhaps from a long-term care facility, aren't harboring an infection already.